Terbinafine: optimization of a LC method for quantitative analysis in pharmaceutical formulations and its application for a tablet dissolution test

Quimica nova

Stulzer, Hellen K.¹  Cardoso, Simone G.²  Borgmann, Sílvia H. M.²  Kuminek, Gislaine²  Bertol, Charise D.²  Tagliari, Monika P.² 

[1] Universidade Estadual de Ponta Grossa, Ponta Grossa, Brasil;Universidade Federal de Santa Catarina, Florianópolis, Brasil

关键词: terbinafine formulations;    method validation;    dissolution test.;   

DOI  :  10.1590/S0100-40422010000800029

学科分类：化学（综合）

来源: Sociedade Brasileira de Quimica

【 摘 要 】

A simple liquidchromatographic method was optimized for the quantitative determination of terbinafinein pharmaceutical hydroalcoholic solutions and tablets, and was also employedfor a tablet dissolution test. The analysis was carried out using a RP-C18(250 mm × 4.6 mm, 5 μm)Vertical® column, UV-Vis detection at 254 nm, and a methanol-water(95:5, v/v) mobile phase at a flow-rate of 1.2 mL min-1. Method validationinvestigated parameters such as linearity, precision, accuracy, robustness andspecificity, which gave results within the acceptable range. The tablets dissolutionwas quite fast: 80% of the drug was dissolved within 15 min.

【 授权许可】

CC BY